Important note: Information in this article was accurate in 1998. The state of the art may have changed since the publication date.
Important note: Information in this article was accurate in 1998. The state of the art may have changed since the publication date.
Reuters NewMedia, Inc.; Thursday June 11, 11:14 am EST
The FDA has designated Sustiva as a fast-track product, which means the regulatory agency will expedite the review of the application, the company said. WILMINGTON, Del., June 11 (Reuters) - DuPont Merck Pharmaceutical Co. said Thursday it had submitted a new drug application to the U.S. Food and Drug Administration for its anti-HIV treatment Sustiva.
The FDA has designated Sustiva as a fast-track product, which means the regulatory agency will expedite the review of the application, the company said. Marketing applications with European and Canadian regulators will also be submitted, the company said.
DuPont Merck is a partnership between chemical giant DuPont Co. (DD - news) and drug company Merck & Co. (MRK - news) that focuses on research and development of pharmaceuticals to treat cardiovascular disease, cancer, arthritis, nervous system disorders and HIV, or human immunodeficiency virus.
The company said Sustiva was first tested in patients two years ago. More than 25 clinical trials evaluating the drug have been conducted.
Sustiva is well tolerated; side effects include rash, nausea, dizziness, diarrhea, headache and insomnia, the company said. Severe rashes have been reported in less than 1 percent of patients.
People do not officially develop AIDS until they are diagnosed with active symptoms, or "opportunistic infections," that are hallmarks of the disease -- including Kaposi sarcoma, a form of skin cancer, and low counts of so-called CD4 white blood cells.
Sustiva would be the first once-a-day pill for use in HIV drug "cocktails," DuPont Merck said. Most HIV drugs must be taken several times a day. The once-a-day feature will help HIV patients stick with their medications, it said. A significant percentage of people taking AIDS drugs fail to take their drugs as scheduled, allowing the AIDS virus to mutate and thereby become resistant to medications, the company said.
"Data collected during the past two years suggest that Sustiva is a potent drug and can be used in a variety of antiretroviral combinations...to achieve HIV-RNA viral suppression below quantifiable levels over an extended period of time," said John Mellors, director of HIV/AIDS Programs at the University of Pittsburgh Medical Center.
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